Evaluation of the diagnostic performance of current and next-generation assays for cardiac troponin I in the BWH-TIMI ED Chest Pain Study
Why the study?
Does an investigational highly sensitive troponin I assay improve diagnostic accuracy for myocardial infarction in patients with non-traumatic chest pain compared to contemporary sensitive assays?
Population
381 patients with non-traumatic chest pain enrolled in the BWH-TIMI ED Chest Pain Study
Comparison
Investigational highly sensitive troponin I… vs Local hospital-based cardiac TnI assay (Siemens)
Design
Cohort, Final diagnosis was adjudicated blinded to investigational cardiac Tn
Follow-up
12-24 hours for biomarker measurement
Authors
Discussion
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Member takes
Implication
S-TnI offers no diagnostic gain over contemporary sensitive assays; leaves open whether higher sensitivity improves MI detection.
Structured PICO
Does an investigational highly sensitive troponin I assay improve diagnostic accuracy for myocardial infarction in patients with non-traumatic chest pain compared to contemporary sensitive assays?
P
Population
381 patients with non-traumatic chest pain enrolled in the BWH-TIMI ED Chest Pain Study
I
Intervention
Investigational highly sensitive troponin I assay (S-TnI; Singulex, detection-limit 0.0002 µg/l) and contemporary sensitive assay (TnI-Ultra; Siemens, detection-limit 0.006 µg/l) measured at baseline, 4-6 h, and 12-24 h
C
Comparator
Local hospital-based cardiac TnI assay (Siemens)
O
Outcome
Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve) for adjudicated myocardial infarctionsurrogate
While investigational highly sensitive troponin assays improve diagnostic accuracy over standard local assays, they do not significantly outperform contemporary sensitive assays, suggesting a plateau in diagnostic return with increasing analytical sensitivity.
Cite This Study
Bonaca et al. (2013) studied this question.